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SILREAL Blog


MFN Pricing Just Made Your China NRDL Strategy a U.S. Liability – And Where Advisory Firms Struggle
The pricing concession your team agrees in a Beijing NRDL negotiation can now move your U.S. valuation model. Most advisors will tell you that. Very few can actually help you model it, defend against it, and close deals that account for it. Here is what the problem looks like, and what working with an advisor who operates in this specific lane actually delivers. The Policy Shift That Changed the Calculus On May 12, 2025, President Trump signed an executive order directing HHS
5 days ago4 min read


Crafting a Digital Health Launch Strategy: Navigating Complex Markets with Precision
Entering the digital health sector requires more than innovative technology. Companies must align regulatory strategy, reimbursement pathways, clinical validation, and provider adoption to successfully launch new solutions. For digital therapeutics, AI diagnostics, and connected health platforms, the go-to-market process is especially complex across global markets such as the United States, Europe, and China. Each region operates under different regulatory systems, data gover
Mar 125 min read


Navigating US-China Healthcare Regulation: Strategic Insights for Senior Executives
In today’s global healthcare landscape, understanding the regulatory frameworks governing the US and China is critical for life sciences companies aiming to expand cross-border. The complexities of healthcare policy in these two economic powerhouses require a nuanced approach that balances compliance, market access, and strategic agility. As senior decision makers, you must navigate these challenges with precision to safeguard investments and accelerate growth. Understanding
Mar 114 min read


Developing a Winning Digital Health Go-to-Market Strategy with Digital Health Regulation and Compliance
In today’s rapidly evolving healthcare landscape, launching a digital health product requires more than just innovation. It demands a comprehensive understanding of regulatory frameworks, market dynamics, and strategic execution. As senior executives steering global policy and market access, you must navigate complex international regulations while aligning your commercial strategy with real-world policy realities. This article provides a clear, actionable roadmap to develop
Feb 14 min read


Strategies for EU China Medtech Market Access: Navigating Expansion into China
Entering the Chinese medtech market presents a unique set of challenges and opportunities for European companies. With its vast population, rapidly evolving healthcare infrastructure, and increasing demand for innovative medical technologies, China is a critical growth frontier. However, success requires more than just product innovation; it demands a deep understanding of regulatory frameworks, market dynamics, and strategic partnerships. In this article, I will share action
Feb 14 min read


From Regulation to Resilience: How U.S. Policy Shifts Are Reshaping Global Pharma
In the pharmaceutical and biotech industry, disruption is not new. The sector has been reshaped over the decades by breakthrough science, digital innovation and changing patient needs. However, today there is another force of change that is shaping the events: U.S policy and geopolitics. To European pharma and biotech leaders, American legislation is becoming the determinant of international rivalry. What is done in Washington does not remain in Washington, it permeates the s
Aug 28, 20255 min read


Unlocking Opportunities in Health-Tech Investments
The health-tech sector is evolving rapidly, driven by innovation and the urgent need for efficient healthcare solutions. As I explore this dynamic landscape, I see vast potential for strategic investments that can transform healthcare delivery and outcomes. The convergence of technology and healthcare opens doors to new business models, improved patient care, and scalable solutions. Understanding how to navigate this space is essential for those aiming to capitalize on its gr
Aug 28, 20254 min read
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